Rhinathiol 2% (carbocisteine) Children and Infant Syrup - Contraindication in children below 2 years old

Sanofi-Aventis Singapore Pte Ltd is informing healthcare professionals that they will be adopting the French authorities' decision to contraindicate the use of Rhinathiol 2% Children and Infant syrup in children below 2 years of age. This decision arose from the French Regulatory Agency's (Afssaps) evaluation of pharmacovigilance data which indicated the risk of aggravation of respiratory symptoms in connection with the use of mucolytic products to treat bronchial secretion in children below 2 years old. This led the French authorities to conclude that the benefit risk ratio of mucolytic products in children less than 2 years of age is no longer favourable and the contraindication of these products in this group of children is required as a precautionary measure. The local package insert for Rhinathiol 2% Children and Infant syrup will be updated to reflect this new contraindication. The packaging will subsequently be changed and renamed as Rhinathiol 2% Children Syrup. The new packaging with the revised package insert is estimated to be implemented in Singapore in February 2011.
Healthcare professional, Therapeutic Products
Published:

Dear Healthcare Professional Letters

12 Dec 2019

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of the letters can be found on the MOH Alert System, which is accessible via the Health Professionals Portal (HPP). HPP is a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://www.moh.gov.sg/hpp/, and follow the procedures below to access the MOH Alert system.

Step 1: On the top navigation ribbon of webpage, select 'For Healthcare Professionals' followed by 'Health Professionals Portal' and click on the choice of profession. User will be redirected to the specific HPP webpage for the selected profession.

Step 2: Click on the Restricted Content icon on the left panel of webpage and login via SingPass.

Step 3: Click on the MOH Alert icon under ‘Applications’ section

Step 4: Click on the Drug Alert tab to view the DHCPLs.